Automated virtual reality cognitive therapy versus virtual reality mental relaxation therapy for the treatment of persistent persecutory delusions in patients with psychosis (THRIVE): a parallel-group, single-blind, randomised controlled trial in England with mediation analyses.
Automated virtual reality cognitive therapy versus virtual reality mental relaxation therapy for the treatment of persistent persecutory delusions in patients with psychosis (THRIVE): a parallel-group, single-blind, randomised controlled trial in England with mediation analyses.
复制标题
自动虚拟现实认知疗法与虚拟现实精神放松疗法治疗精神病患者持续性被害妄想（THRIVE）：在英国进行的一项平行组、单盲、随机对照试验，并进行中介分析。
DOI：
10.1016/s2215-0366(23)00257-2
复制
发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Freeman D
中科院分区：
文献类型：
--
作者：
Freeman D
背景顽固性妄想是一个主要的精神问题，通常对标准的药物或心理治疗没有足够的反应。我们开发了一种新的简短的自动化虚拟现实（VR）认知治疗，有可能很容易地用于临床服务。我们的目的是比较VR认知疗法与替代VR疗法（精神放松），重点是了解潜在的作用机制。MethodsTHRIVE是一个平行组，单盲，随机对照试验，在英国国家卫生服务信托在英格兰。如果参与者年龄在16岁或以上，有持续（至少3个月）的迫害妄想，至少有50%的信念，报告与其他人在外面时感到受到威胁，并且有非情感性精神障碍的转诊临床团队的初步诊断，则被纳入研究。我们将患者随机（1：1）分配至THRIVE VR认知治疗组或VR精神放松组，使用随机变化区组大小的排列区组算法，按妄想的严重程度分层。继续对所有参与者进行康复护理。每种VR治疗在大约4周的时间内分4次进行，由助理心理学家或临床心理学家提供支持。试验评估员对组分配设盲。在0、2（治疗中点）、4（主要终点，治疗结束）、8、16和24周时评估结局。主要结局是迫害妄想信念，由精神病症状评定量表（PSYRATS;评分为0-100%）评估。在意向治疗人群中进行结局分析。我们评估了干预措施的治疗可信度和预期，以及认知干预旨在针对的两种机制（防御行为和安全信念）。本试验在ISRCTN登记研究中进行了前瞻性登记，ISRCTN 12497310。结果从2018年9月21日至2021年5月13日（由于2020年3月16日至2020年9月14日的COVID-19大流行限制而暂停），我们招募了80名患有持续迫害妄想的参与者（49例[61%]男性，31例[39%]女性，平均年龄40岁[SD 13，范围18-73]，64例[80%]白色，6例[8%]黑人，1例[1%]印度人，3例[4%]巴基斯坦人和6例[8%]其他人种或种族）。我们将39名（49%）参与者随机分配到VR认知治疗组，41名（51%）参与者分配到VR心理放松组。33名（85%）被分配到VR认知治疗的参与者参加了所有四个会议，35名（85%）被分配到VR精神放松的参与者参加了所有四个会议。我们发现两种VR干预在参与者对治疗可信度的评分（调整后的平均差异-1 statist 55 [95%CI-3 statist 68至0.58]; p= 0.15）和结局预期（-0 statist 91 [-3 statist 42至1.61]; p= 0.47）方面没有显著差异。77名（96%）参与者在主要时间点提供了随访数据。与VR精神放松相比，VR认知疗法并没有导致迫害妄想的更大改善（校正的平均差异-2统计16 [-12统计77至8.44]; p= 0.69）。与VR心理放松相比，VR认知疗法并没有导致防御行为的使用更大程度的减少（调整后的平均差异为-0 statist 71 [-4 statist 21至2.79]; p= 0.69）或安全信念的更大程度的增加（-5 statist 89 [-16 statist 83至5.05]; p= 0.29）。有17起与试验无关的严重不良事件（VR认知治疗组7名参与者发生10起事件，VR精神放松组5名参与者发生7起事件）。
BackgroundPersecutory delusions are a major psychiatric problem that often do not respond sufficiently to standard pharmacological or psychological treatments. We developed a new brief automated virtual reality (VR) cognitive treatment that has the potential to be used easily in clinical services. We aimed to compare VR cognitive therapy with an alternative VR therapy (mental relaxation), with an emphasis on understanding potential mechanisms of action.MethodsTHRIVE was a parallel-group, single-blind, randomised controlled trial across four UK National Health Service trusts in England. Participants were included if they were aged 16 years or older, had a persistent (at least 3 months) persecutory delusion held with at least 50% conviction, reported feeling threatened when outside with other people, and had a primary diagnosis from the referring clinical team of a non-affective psychotic disorder. We randomly assigned (1:1) patients to either THRIVE VR cognitive therapy or VR mental relaxation, using a permuted blocks algorithm with randomly varying block size, stratified by severity of delusion. Usual care continued for all participants. Each VR therapy was provided in four sessions over approximately 4 weeks, supported by an assistant psychologist or clinical psychologist. Trial assessors were masked to group allocation. Outcomes were assessed at 0, 2 (therapy mid-point), 4 (primary endpoint, end of treatment), 8, 16, and 24 weeks. The primary outcome was persecutory delusion conviction, assessed by the Psychotic Symptoms Rating Scale (PSYRATS; rated 0–100%). Outcome analyses were done in the intention-to-treat population. We assessed the treatment credibility and expectancy of the interventions and the two mechanisms (defence behaviours and safety beliefs) that the cognitive intervention was designed to target. This trial is prospectively registered with the ISRCTN registry, ISRCTN12497310.FindingsFrom Sept 21, 2018, to May 13, 2021 (with a pause due to COVID-19 pandemic restrictions from March 16, 2020, to Sept 14, 2020), we recruited 80 participants with persistent persecutory delusions (49 [61%] men, 31 [39%] women, with a mean age of 40 years [SD 13, range 18–73], 64 [80%] White, six [8%] Black, one [1%] Indian, three [4%] Pakistani, and six [8%] other race or ethnicity). We randomly assigned 39 (49%) participants assigned to VR cognitive therapy and 41 (51%) participants to VR mental relaxation. 33 (85%) participants who were assigned to VR cognitive therapy attended all four sessions, and 35 (85%) participants assigned to VR mental relaxation attended all four sessions. We found no significant differences between the two VR interventions in participant ratings of treatment credibility (adjusted mean difference –1·55 [95% CI –3·68 to 0·58]; p=0·15) and outcome expectancy (–0·91 [–3·42 to 1·61]; p=0·47). 77 (96%) participants provided follow-up data at the primary timepoint. Compared with VR mental relaxation, VR cognitive therapy did not lead to a greater improvement in persecutory delusions (adjusted mean difference –2·16 [–12·77 to 8·44]; p=0·69). Compared with VR mental relaxation, VR cognitive therapy did not lead to a greater reduction in use of defence behaviours (adjusted mean difference –0·71 [–4·21 to 2·79]; p=0·69) or a greater increase in belief in safety (–5·89 [–16·83 to 5·05]; p=0·29). There were 17 serious adverse events unrelated to the trial (ten events in seven participants in the VR cognitive therapy group and seven events in five participants in the VR mental relaxation group).InterpretationThe two VR interventions performed similarly, despite the fact that they had been designed to affect …
登录
查看更多内容
影响因子：
4.5
作者：
Freeman, Daniel;Taylor, Kathryn M.;Waite, Felicity
通讯作者：
Waite, Felicity
DOI：
10.1192/bjp.bp.115.176438
发表时间：
2016-07
期刊：
The British journal of psychiatry : the journal of mental science
影响因子：
--
作者：
Freeman D;Bradley J;Antley A;Bourke E;DeWeever N;Evans N;Černis E;Sheaves B;Waite F;Dunn G;Slater M;Clark DM
通讯作者：
Clark DM
虚拟现实放松在精神分裂症中的治疗应用：一项试点研究
影响因子：
11.3
作者：
Ophélie Rault;H. Lamothe;A. Pelissolo
通讯作者：
A. Pelissolo
影响因子：
5.9
作者：
Clark, David M.;Ehlers, Anke;Wild, Jennifer
通讯作者：
Wild, Jennifer
DOI：
10.1016/s0005-7916(00)00012-4
发表时间：
2000-06-01
影响因子：
1.8
作者：
Devilly, GJ;Borkovec, TD
通讯作者：
Borkovec, TD